Methods

This was a 6-month, open-label, single-center study using a cross-over design.

14 subjects were randomized to one of two protocols: once daily insulin glargine or twice-daily 75%/25% neutral protamine lispro/lispro mix.

At 12 weeks, the subjects were crossed-over to the opposite protocol.

During each period, insulin doses were titrated to target fasting blood glucose of 90–110mg/dL.

At baseline and after the two 12-week treatment periods, subjects were studied in the Clinical Research Center; they consumed three liquid mixed isocaloric meals at 4-h intervals, and glucose, free fatty acids (FFA), lipids, and α-dicarbonyls (3-deoxyglucosone [3-DG] and methylglyoxal [MG]) were measured before and after each meal.

Patient data were analyzed in the context of their assigned insulin strategy groups.

Results

Both insulin regimens led to a significant improvement in glycemic profiles, including fasting glucose and HbA1c, compared to baseline.